HIPAA Authorization Agreement – Authorization to Use and Release Health Information for a Research Study

Insert Study Title

State and Federal laws, including the Health Insurance Portability and Accountability Act (HIPAA), require researchers to protect your health information. This form describes how researchers, with your authorization (permission), may use and release your protected health information for this research study. Please read this form carefully.

You have been asked to take part in a research study. The study is described to you in a separate consent form. By signing this HIPAA Authorization Agreement you are permitting Insert PI Name and his/her research team to create, get, use, store, and share protected health information that identifies you for the purposes of this research. Protected health information may include results of tests, procedures or surveys that are part of the research, as well as information that can identify you, such as your name, date of birth and medical record number.

Optional Photo Consent [omit this paragraph if research protocol does not require photos]: You authorize Insert PI Name and his/her research team to photograph / film you while participating in this research study. You understand that the negatives, prints, and/or tapes prepared from such photographs or films will be included as part of your protected health information that is described in this Authorization. If you sign this form, the researchers may use or share these photographs and/or films in the same way that they use your protected health information. The ways that your protected health information may be used or shared is described below. You understand that the term “photograph” as used in this Authorization shall mean motion picture or still photography in any format as well as videotape, video disc or any other mechanical means of recording or reproducing images.

You have the right to see and copy your protected health information related to the study for as long as the study doctor holds this information. However, to make sure the scientific findings of this study are accurate, you may not be able to review some of your records related to this study until after the study is completed.

Research use of your protected health information

If you sign this form, the researchers may use or release your health information during the conduct of the research with:

• Each other and with other researchers involved in the study

• Law enforcement or other agencies, when required by law

• Summa Health System’s Institutional Review Board (a group of people who protect the rights of research subjects)

• The sponsor (funding organization) of this research

• Representatives of government agencies (i.e. Food and Drug Administration and the Office of Human Research Protection)

• Authorized representatives from internal hospital operations (i.e. quality assurance)

Description of protected health information that may be used and released

Health information includes all information created and/or collected during the research as described in the research study consent form entitled Insert Study Title. Health information in your medical record may be used and released if it is needed for the research; for example, past medical conditions or medications or information related to illness or hospitalizations that occur during your participation in the research.

Health information includes: names, initials, address, telephone number, date of birth, social security number, gender, race, height, weight, results of physical exams, blood test results, surgery outcomes and complications, pregnancy tests, etc.

Protection of your health information

The researchers and Insert Sponsor agree to protect your health information and will only share this information as described in this Authorization and the research consent form.

Summa Health System will make every effort to keep your research records private, but confidentiality cannot be assured with complete confidence. For example, Summa Health System has no control over the use of this information once it is released.

The information about you that is collected in this study will be shared with the study sponsor and may be combined with information gathered from public sources or other research studies. This information may be used by the sponsor for purposes unrelated to this research and could potentially be used to identify you.

Expiration of Authorization

This Authorization does not have an expiration date but can be canceled sooner if you decide to withdraw your permission.

Withdrawal or removal from the study

You may change your mind and cancel this Authorization at any time. To cancel this Authorization, you must write to: Insert PI Name and Address.

If you cancel this Authorization, you may no longer be allowed to take part in the research study. Even if you cancel this Authorization, the researchers may still use and release health information they have already obtained to maintain the integrity and reliability of the research, and to report any adverse (bad) effects that may have happened to you.

Contact information for questions about my rights under HIPAA

If you have questions or concerns regarding your privacy rights under HIPAA, you should contact the Privacy Officer at 330-375-6665.

Right to refuse to sign this Authorization

You do not have to sign this Authorization. However, because your health information is required for research participation, if you decide not to sign this Authorization form, it will only mean you cannot take part in this research. Not signing this form will not affect your non-research related treatment, payment or enrollment in any health plans, or your eligibility for other medical benefits.

Signature of subject

I have read (or someone has read to me) the above information. I have been given an opportunity to ask questions, and my questions have been answered to my satisfaction. I authorize the use and release of my protected health information for this research. I will be given a signed copy of this Authorization form.

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Printed Name of Subject

____________________________________ _______________

Signature of Subject Date

____________________________________________ _______________

Signature of Person Obtaining Authorization Agreement Date

Version Number: __________

Date: _____________